iHealth ICO-3000 Operating instructions

iHealth® COVID-19 Antigen Rapid Test

Healthcare Provider Instructions for Use

Model: ICO-3000/ICO-3001/ICO-3002

For use with anterior nasal swab specimens

For in vitro Diagnostic Use Only

This product has not been FDA cleared or approved; but has been authorized by FDA

under an Emergency Use Authorization (EUA)

INTENDED USE

The iHealth® COVID-19 Antigen Rapid Test is a lateral flow assay intended for the qualitative

detection of nucleocapsid protein antigen from SARS-CoV-2.

This test is authorized for non-prescription home use with self-collected anterior nasal (nares)

swab samples from individuals aged 15 years or older with symptoms of COVID-19 within

the first 7 days of symptom onset. This test is also authorized for non-prescription home use

with adult-collected anterior nasal (nares) swab samples from individuals aged 2 years or

older with symptoms of COVID-19 within the first 7 days of symptom onset.

This test is also authorized for non-prescription home use with self-collected anterior nasal

(nares) swab samples from individuals aged 15 years or older, or adult-collected anterior

nasal (nares) swab samples from individuals aged 2 years or older, with or without

symptoms or other epidemiological reasons to suspect COVID-19 when tested twice over

three days with at least 24 hours (and no more than 48 hours) between tests.

The iHealth® COVID-19 Antigen Rapid Test does not differentiate between SARS-CoV and

SARS-CoV-2.

Results are for the identification of the SARS-CoV-2 nucleocapsid protein antigen. The

antigen is generally detectable in anterior nasal swab specimens during the acute phase of

infection. Positive results indicate the presence of viral antigens, but clinical correlation with

past medical history and other diagnostic information is necessary to determine infection

status. Positive results do not rule out bacterial infection or co-infection with other viruses.

The agent detected may not be the definite cause of disease. Individuals who test positive

with the iHealth® COVID-19 Antigen Rapid Test should self-isolate and seek follow-up care

with their physician or healthcare provider as additional testing may be necessary.

Negative results are presumptive and confirmation with a molecular assay, if necessary for

patient management, may be performed. Negative results do not rule out COVID-19 and

should not be used as the sole basis for treatment or patient management decisions,

including infection control decisions. Negative results should be considered in the context of

an individual’s recent exposures, history and the presence of clinical signs and symptoms

consistent with COVID-19.

For serial testing programs, additional confirmatory testing with a molecular test for negative

results may be necessary, if there is a high likelihood of SARS-CoV-2 infection, such as in an

individual with as a close contact with COVID-19 or with suspected exposure to COVID-19

or in communities with high prevalence of infection. Additional confirmatory testing with a

molecular test for positive results may also be necessary, if there is a low likelihood of

SARS-CoV-2 infection, such as in individuals without known exposures to COVID-19 or

residing in communities with low prevalence of infection.

Individuals who test negative and continue to experience COVID-19 like symptoms of fever,

cough and/or shortness of breath may still have SARS-CoV-2 infection and should seek

follow up care with their physician or healthcare provider.

Individuals should provide all results obtained with this product to their healthcare provider

for public health reporting or by following the mobile application instructions for self-reporting.

All healthcare providers will report all test results they receive from individuals who use the

authorized product to relevant public health authorities in accordance w ith local, state, and

federal requirements using appropriate LOINC and SNOMED codes, as defined by the

Laboratory In Vitro Diagnostics (LIVD) Test Code Mapping for SARS-CoV-2 Tests provided

by CDC.

The iHealth® COVID-19 Antigen Rapid Test is authorized for non-prescription self-use and/or,

as applicable for an adult lay user testing another person aged 2 years or older. The

iHealth® COVID-19 Antigen Rapid Test is only for use under the Food and Drug

Administration’s Emergency Use Authorization.

PRODUCT DESCRIPTION

The iHealth® COVID-19 Antigen Rapid Test requires the following elements for operation.

Materials provided in the Test Kit:

Kit components

Quantity

1 test Kit

2 tests Kit

5 tests Kit

40 tests Kit

COVID-19 Test Card(s)

1 ea/box

2 ea/box

5 ea/box

40 ea/box

Nasal Swab(s)

1 ea/box

2 ea/box

5 ea/box

40 ea/box

Tube(s)

1 ea/box

2 ea/box

5 ea/box

40 ea/box

Lay User Instruction for Use

1 ea/box

For Healthcare Provider Instructions for Use, please see the company website:

https://www.ihealthlabs.com

COVID-19 Test Card(s)

Tube(s) pre-filled or empty Tube(s) with sealed Solution(s)

Swab(s)

iHealth® COVID-19 Antigen Rapid Test components

Materials required but are not provided in the kit:

• Smartphone (supplied by the user. iOS 12 or above. android 6.0 or above)

• User is required to download the “iHealth COVID-19 Antigen Rapid Test” App for iOS

or Android phones. User should follow the step-by-step instructions in-app to

complete the test.

PRINCIPLE OF PROCEDURES

The iHealth® COVID-19 Antigen Rapid Test employs lateral flow immunoassay technology.

Using this test allows for the rapid detection of nucleocapsid protein from SARS-CoV-2.

To begin the test, a self-collected anterior nares swab samples in individuals aged 15 and

older or individuals between the age of 2 to 14 with a swab collected by a parent or guardian

is inserted into the Tube. The liquid in tube interacts with the specimen and facilitates

exposure of the appropriate viral antigens to the antibodies used in the test. The liquid in

tube now containing the specimen is added to the Sample Port of the COVID-19 Te s t Card.

If the extracted specimen contains SARS-CoV-2 antigens, a pink-to-purple T Line, along

with a pink-to-purple C Line will appear on the COVID-19 Test Card indicating a positive

result. If SARS-CoV-2 antigens are not present, or present at very low levels, only a

pink-to-purple C Line will appear.

WARNINGS AND PRECAUTIONS

• For in vitro diagnostic use only.

• This product has not been FDA cleared or approved, but has been authorized by FDA

under an Emergency Use Authorization (EUA).

• The emergency use of this product is only authorized for the duration of the declaration

that circumstances exist justifying the authorization of emergency use of in vitro

diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the

Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the

declaration is terminated or authorization is revoked sooner.

• Laboratories within the United States and its territories are required to report results to

the appropriate public health authorities

• This product has been authorized only for the detection of proteins from SARS-CoV-2,

not for any other viruses or pathogens.

• This test is intended as an aid in the diagnosis of COVID-19 by detecting viral antigens,

but should not be used as a sole criterion for the determination of SARS-CoV-2 infection.

Other laboratory tests and clinical information (signs and symptoms) should be used

and considered for diagnosis.

• Do not use any test component after the expiration date which is printed on the outer

packaging.

• Do not use the COVID-19 Test Card if the pouch is damaged or if the seal is broken.

• Do not reuse any test component.

• To obtain accurate results, the test must be performed as indicated in the Instructions for

Use.

• Inadequate or inappropriate sample collection may yield false test results.

• Do not touch the tip of the swab before and after collecting the sample from the nostrils.

• Test samples immediately after collection, but no more than 4 hours after specimen

collection before placement into extraction buffer or up to 2 hours after placement into

extraction buffer, if kept at room temperature.

• Be sure to read test result after 15 minutes. Do not read results after 30 minutes.

• Do not ingest extraction liquid

• Keep test kit and components out of the reach of children and pets before and after use.

• Avoid contact with skin and eyes.

• The reagent in the extraction liquid contains ProClin® 300 which may cause skin and

eye irritation. If the solution makes contact w ith the skin or eye, wash/flush with copious

amounts of water. If skin irritation or rash occurs get medical advice/attention.

• Dispose of used specimens and test components in accordance with Federal, State, and

Local requirements.

Important Notes

This test kit is intended to be used as an aid in the clinical diagnosis of a current COVID-19

infection. Do not use this test kit as the only guide to manage your illness.

LIMITATIONS

• Do not use on anyone under 2 years old.

• Children aged 2-14 years should be tested by an adult.

• Do not use on anyone who is prone to nosebleeds or has had facial or head

injury/surgery in the last 6 months.

• Testing for asymptomatic individuals should be performed at least twice over three

days, with at least 24 hours and no more than 48 hours between tests. You may need

to purchase additional tests to perform this serial (repeat) testing.

• There is a higher chance of false negative results with home use tests than with

laboratory-based molecular tests. This means that there is a higher chance this test

will give you a negative result when you have COVID-19.

• Serial testing (i.e., testing every day or every other day) is more likely to detect

COVID-19, especially when you do not have any symptoms.

• The test detects both viable (live) and nonviable SARS-CoV-2. Test performance

depends on the amount of virus (antigens) in the sample and may or may not

correlate with viral culture results performed on the same sample.

• A negative test result may occur if the level of antigen in the sample is below the

detection limit of the test.

• Failure to follow the test procedure correctly may results in false negative or false

positives results and/or invalidate the test result.

• Test results must be evaluated in conjunction with other clinical data available to the

physician.

• Positive test results do not exclude co-infection with other pathogens.

• Negative test results are not indicative of the presence/absence of other viral or

bacterial pathogens.

• Negative results should be treated as presumptive and confirmed with an

FDA-authorized molecular assay, if necessary, for clinical management.

• Performance of nasal swabs collected from patients without symptoms or other

epidemiological reasons to suspect COVID-19 infection or for serial screening, when

tested twice over two to three days with at least 24 but not more than 48 hours

between tests has not yet been determined; a study to support use will be completed.

• If the differentiation of specific coronaviruses and strains is needed, additional testing,

in consultation with state or local public health departments, is required.

• The amount of antigen in a sample may decrease as the duration of illness increases.

Specimens collected after seven days are more likely to be negative compared to

RT-PCR.

• The performance of this test was established based on the evaluation of a limited

number of clinical specimens collected between May, 2021 and October, 2021. The

clinical performance has not been established in all circulating variants but is

anticipated to be reflective of the prevalent variants in circulation at the time and

location of the clinical evaluation. Performance at the time of testing may vary

depending on the variants circulating, including newly emerging strains of

SARS-CoV-2 and their prevalence, which change over time.

• The iHealth® COVID-19 Antigen Rapid Test does not differentiate between

SARS-CoV and SARS-CoV-2.

• False negative results may occur in individuals who have indicated or whose clinical

status or history would indicate they are currently taking high doses of biotin. Biotin

levels of 1 µg/mL and greater have been demonstrated to result in false negative test

results

Hazardous Ingredients for Reagent Solution

The Extraction Reagent contains potentially harmful chemicals (see table below). If the test

solution contacts the skin or eye, flush with copious amounts of water. If irritation persists,

seek medical advice: visit https://www.poison.org/contact-us Or call 1-800-222-1222.

Chemical Name Harms (GHS Code) for each ingredient Concentration

Triton

X-100/9002-93-1

Harmful if swallowed (H302)

Cause skin irritation(H315)

Cause serious eye damage(H318)

0.1%

ProClin® 300

Harmful if swallowed (H302)

Harmful if inhaled (H332)

Causes severe skin burns and eye damage

(H314)

May cause an allergic skin reaction (H317)

0.05%

STORAGE CONDITIONS

Store iHealth® COVID-19 Antigen Rapid Test in a dry location between 36-86 °F (2-30 °C).

Ensure all test components are at room temperature 65-86 °F (18-30 °C) before use. The

COVID-19 Test Card inside the foil pouch should be used within 1 hour after opening. The

iHealth® COVID-19 Antigen Rapid Test is stable before the expiration date marked on the

packaging.

QUALITY CONTROL

A procedural internal control is built in the “control line (c)” of the device and is used to

ensure that the applied specimen has migrated well into the device. It is coated with goat

anti-rabbit IgG and a red colored line should appear after sample was added.

TEST PROCEDURE

Download App: Scan the QR code (below) to download the “iHealth COVID-19 Antigen

Rapid Test” App through your Smartphone (iOS12.0+, Android 6.0+). For a full list of

compatible smartphone visit: https://ihealthlabs.com/pages/support-ICO3000

Watch Video in App: Each step has a corresponding instructional video in the App. Watch

the video and perform the test according to the instructions.

Instructions

The instructions provided here include all the steps of the test. Specific, detailed video

instructions on how to perform this test are in the “iHealth COVID-19 Antigen Rapid Test”

App.

1) Prepare Materials

You may have Test Set 1 OR Test Set 2 in the package. Please follow proper steps based on

the specific set you received.

• Test Set 1: Open the package, take out the COVID-19 Test Card in Pouch, the

Tube pre-filled w ith the extraction solution and the Swab. When you are ready to

proceed with the test, open the foil pouch of the COVID-19 Test Card.

Please go directly to Step 2 Collect Sample.

• Test Set 2: Open the package, take out the COVID-19 Test Card in Pouch, empty

Tube, sealed Solution and the Swab. When you are ready to proceed with the test,

open the foil pouch of the COVID-19 Test Card.

Please look carefully, there are two Edges on the empty tube. Then squeeze

the sealed solution completely into the empty tube.

Please confirm the liquid level with or above Edge 2, then go to Step 2 Collect

Sample.

NOTE:

It is acceptable if the liquid level is above Edge 2. However, please do not

proceed with this test, if the liquid level is below Edge 2, as this may result in

false or invalid results.

2) Collect Sample

1. Remove the swab from its package, being careful not to touch the tip of the swab.

Please keep the swab package for later use.

2. Gently insert the entire absorbent tip of the swab (usually 1/2 to 3/4 of an inch) into

your nostril.

Note: With children, the maximum depth of insertion into the nostril may be less than ¾ of an

inch, and you may need to have a second person to hold the child’s head while swabbing.

3. Firmly and slowly brush against insides of nostril in a circular motion against the nasal

wall at least 5 times. Using the same swab, repeat the same sample collection

procedure for the other nostril. Take at least 15 seconds to collect the specimen and

be sure to collect any nasal drainage on the swab. Be sure to brush BOTH nostrils

with the SAME SWAB.

Note: Failure to swab properly may cause false negative results.

3) Process Sample

1. Tap the tube vertically on the table and twist the large orange cap to open the tube.

2. Insert the swab into the tube, touch the bottom of the tube with the swab tip, and stir at

least 15 times.

3. Squeeze the sides of the tube to express as much liquid as possible from the swab,

and then remove the swab.

Note: If you don't squeeze the swab, there may not be sufficient sample material to perform

the test properly (i.e., potentially resulting in a false negative result).

4. Screw back the large orange cap, put the swab back into the package. Safely dispose

of the swab and the package.

4) Add Sample

Twist to open the small white cap of the tube. Add 3 drops of sample to the Sample Port of

the COVID-19 Test Card. Screw back the small white cap.

Note: A false negative or invalid result may occur if too little solution is added to the test

card.

5) Wait 15 minutes

Start the timer by clicking the “Start Timer” button on the App, immediately after adding

sample to the Sample Port. The result will be ready in 15 minutes.

Note: DO NOT interpret your test result until after your 15-min timer has completed, as the T

line may take as long as 15 minutes to appear.

6) Read Result

Results should not be read after 30 minutes.

Note: A false negative or false positive result may occur if the test result is read before 15

minutes or after 30 minutes

Result shown at 2x.

7) Test Result Explanation

Positive Result

A POSITIVE result must show BOTH a C line and a T line. A positive result means that viral

antigens from COVID-19 were detected and the individual is positive for COVID-19.

Below are photos of actual positive tests. Please note that the T line may be faint.

• Persons who test positive should self-isolate and seek follow up care with their

physician or healthcare provider as additional testing and public health reporting may

be necessary.

Negative Result

A NEGATIVE result will show ONLY a C line. A negative result means that viral antigens

from COVID-19 were not detected and that the individual is presumed negative for

COVID-19.

• Please note that negative results do not rule out COVID-19.

• In case of negative test result: Continue to follow all social distancing

recommendations and take protective measures. If suspicions of infection persist

and/or your first test is negative, repeat the test after 1 - 2 days and consult your

healthcare provider or local COVID-19 center.

• Note: A negative result is presumptive and confirmation with a molecular assay, if

necessary, for patient management may be performed.

• Individuals without symptoms that test negative should be tested again with at least

24 hours and no more than 48 hours between tests. Additional confirmatory testing

with a molecular test for negative results may be necessary after second negative

result for asymptomatic patients, if there is a high likelihood of SARS-CoV-2 infection,

such as in an individual with as close contact with COVID-19 or with suspected

exposure to COVID-19 or in communities with high prevalence of infection. Additional

confirmatory testing with a molecular test for positive results may also be necessary, if

there is a low likelihood of SARS-CoV-2 infection, such as in individuals without

known exposures to SARS-CoV-2 or residing in communities with low prevalence of

infection.

Invalid Result

If there is NO LINE, or if there is ONLY a T line, the test is INVALID. Invalid result means that

the test did not function correctly. You will need to retest with a new test kit. If upon

retesting, the test result is still invalid, contact your doctor or local COVID-19 center. An

invalid result does not indicate if the individual did or did not have COVID-19 and should be

repeated.

8) Dispose the Test Kit

After test is completed, dispose of all kit components in trash.

9) Report Test Result

Report the result following the App instructions or share your test result with your healthcare

provider.

CLINICAL PERFORMANCE

Clinical performance characteristics of iHealth® COVID-19 Antigen Rapid Test was

evaluated in a total of five (5) investigational sites throughout the U.S. A total of 139

individuals with signs and symptoms of COVID-19 within the first seven (7) days of symptom

onset completed the study and obtained a valid result. Each Subject was provided a iHealth®

COVID-19 Antigen Rapid Test. Under the observation of a clinical site staff member trained

as a proctor, subjects fifteen (15) years and older independently collected an anterior nasal

sample, conducted the test, interpreted and reported their self-test result. The parents of

subjects two (2) to fourteen (14) years of age collected the anterior nasal sample, conducted

the test, interpreted and recorded the test result for the child. The iHealth® COVID-19

Antigen Rapid Test results were compared to highly sensitive molecular FDA EUA

Authorized SARS-CoV-2 assays to determine test performance. The iHealth® COVID-19

Antigen Rapid Test when conducted by a lay user correctly identified 94.3% of positive

samples. Additionally, the iHealth® COVID-19 Antigen Rapid Test correctly identified 98.1%

of negative samples. The performance is shown in the following table.

iHealth®

COVID-19 Antigen Rapid Te s t

Comparator Method

Positive

Negative

Total

Positive

Negative

102

104

Total

104

139

Positive Agreement: (33/35) 94.3%; 95% Confidence Interval: 81.4% to 98.4%

Negative Agreement: (102/104) 98.1%; 95% Confidence Interval: 93.3% to 99.5%

Of the 2 false negative samples, one was positive on a second FDA EUA high sensitivity

molecular SARS-CoV-2 assay, the other one was negative on a second FDA EUA high

sensitivity molecular SARS-CoV-2 assay.

b Of the 2 false positive samples, one was negative on a second FDA EUA high sensitivity

molecular SARS-CoV-2 assay, the other was inconclusive on a second FDA EUA high

sensitivity molecular SARS-CoV-2 assay.

2 samples generated an invalid COVID-19 Antigen Rapid Test result.

Age and gender distribution and positive rate

of symptomatic

subjects within first 7 days of symptom onset

Age Group

(years)

Female

Male Positive Positivity Rate % (total

positive/total tested)

2 to 13 6 8 3 21.4% (3/14)

14 to 24 15 12 3 11.1% (3/27)

25 to 64 46 44 28 31.1% (28/90)

≥65

12.5% (1/8)

Total 72 67 35 25.2% (35/139)

Positive results broken down by days since symptom onset

Days Since Symptom

Onset

RT-PCR

Positive (+)

iHealth test

Positive (+)

PPA 95 % Confidence

Interval

100.0%

20.7% - 100.0%

100.0%

43.8% - 100.0%

66.7%

20.8% - 93.9%

100.0%

56.6% -100.0%

100.0%

75.7% - 100.0%

100.0%

61% - 100.0%

80.0%

37.6% - 96.4%

All specimens

94.3%

81.4% - 98.4%

Additional asymptomatic individuals and individuals beyond the seven days of symptom

onset were tested, but excluded from the primary performance calculations because they

were not included in the intended use. A higher proportion of low positive specimens were

observed in these populations, resulting in PPAs between of 85-88% in these individuals.

PERFORMANCE CHARACTERISTICS

Limit of Detection (LOD)

The LOD of iHealth® COVID-19 Antigen Rapid Test w as established by using limiting

dilutions of heat inactivated SARS-CoV-2 virus(USA-WA1/2020) sample. The strain was

spiked into clinical matrix prepared by mixing raw nasal fluid in saline and confirmed again

as SARS-CoV-2 negative by RT-PCR.

The estimated LoD found from the initial 4 different concentrations test by testing 5

replicates. At each dilution, samples were added to swabs and then tested through the full

assay workflow, from processing in the extraction reagent to read test result.

A concentration was chosen between the last dilution to give five positive results and the first

to give five negative results. Using this concentration, the LoD was further refined with a 2-

fold dilution series. The LOD was determined as the lowest virus concentration that w as

detected ≥ 95% of the time (concentration at which at least 19 out of 20 replicates tested

positive).

The iHealth® COVID-19 Antigen Rapid Test LOD in natural nasal swab matrix is 20×103

TCID50/mL.

Cross Reactivity (Analytical Specificity) and Microbial Interference

The potential cross-reactivity (exclusivity) of a panel of common organisms was evaluated

with SARS-CoV-2 negative samples using the iHealth® COVID-19 Antigen Rapid Test.

Potential microbial interference was evaluated with samples containing heat inactivated

SARS-CoV-2 virus(USA-WA1/2020) sample at approximately 3 x LoD.

A total of 38 commensal and pathogenic microorganisms (13 bacteria and 25 viruses) that

may be present in the nasal cavity were evaluated in this study. Each of the organism and

viruses were tested in five replicates in the absence or presence of heat inactivated

SARS-CoV-2 virus.

No cross-reactivity or interference was observed with the following microorganisms when

tested at the concentration presented in the table below.

List of Organism Concentration

tested

Cross-reactivity

results

Microbial

Interference

results

Other high

priority

pathogens

from the

same genetic

f a m ily

Human coronavirus 229E

3.74 ×104TCID

/mL

No cross-rea ctivity

No interference

Human coronavirus OC43

2.51

105TCID

/mL

No cross-rea ctivity

No interference

Human coronavirus NL63

1.36

105TCID

/mL

No cross-rea ctivity

No interference

MERS-coronavirus 1.36×105TCID50/mL No cross-rea ctivity No interference

High priority

orga nisms

likely in the

circula ting

a rea

Adenovirus Type 1

2.04

TCID

/mL

No cross-rea ctivity

No interference

Adenovirus Type 4

2.09

TCID

/mL

No cross-rea ctivity

No interference

Adenovirus Type 7A

2.04

TCID

/mL

No cross-rea ctivity

No interference

Adenovirus Type 8

1.13

TCID

/mL

No cross-rea ctivity

No interference

Adenovirus Type 31

1.13

U/m L

No cross-rea ctivity

No interference

Adenovirus Type 41

9.36

TCID

/mL

No cross-rea ctivity

No interference

Human Metapneumovirus

3(hMPV-3) Type B1 3.11×104TCID50/mL No cross-rea ctivity No interference

Human Metapneumovirus

4(hMPV-4) Type B2 5.25×105TCID50/mL No cross-rea ctivity No interference

Human Metapneumovirus

9(hMPV-9) Type A1 9.36×104TCID50/mL No cross-rea ctivity No interference

Parainfluenza Virus Type 1 6.30×105TCID50/mL No cross-rea ctivity No interference

Parainfluenza Virus Type 2

7.55

TCID

/mL

No cross-rea ctivity

No interference

Parainfluenza Virus Type 3

2.29

TCID

/mL

No cross-rea ctivity

No interference

Parainfluenza Virus Type 4A

4.50

TCID

/mL

No cross-rea ctivity

No interference

Parainfluenza Virus Type 4B

1.36

TCID

/mL

No cross-rea ctivity

No interference

Influenza A H3N2 Virus

1.13

TCID

/mL

No cross-rea ctivity

No interference

Influenza B Virus

3.74

TCID

/mL

No cross-rea ctivity

No interference

Enterovirus Type 68

7.55

TCID

/mL

No cross-rea ctivity

No interference

Enterovirus Type 71

2.29

TCID

/mL

No cross-rea ctivity

No interference

Respiratory Syncytial Virus

Type A (RSV-A) 1.90×106TCID50/mL No cross-rea ctivity No interference

Respiratory Syncytial Virus

Type B (RSV-B) 3.74×104TCID50/mL No cross-rea ctivity No interference

Rhinovirus Type 1A 9.36×104TCID50/mL No cross-rea ctivity No interference

Haemophilus influenzae

6.75

108CFU/mL

No cross-rea ctivity

No interference

Streptococcus pneumoniae

1.80

108CFU/mL

No cross-rea ctivity

No interference

Streptococcus pyogenes

2.04

109CFU/mL

No cross-rea ctivity

No interference

Candida albicans

3.15

CFU/mL

No cross-rea ctivity

No interference

Pooled human nasal wash –

representative of normal

respiratory microbial flora

- No cross-rea ctivity No interference

Bordetella pertussis 3.22×109CFU/mL

No cross-rea ctivity No interference

Mycoplasma pneumoniae 1.35×108CFU/mL

No cross-rea ctivity No interference

Chlamydia pneumoniae

8.65

107IFU/mL

No cross-rea ctivity

No interference

Legionella pneumophila

7.10

109CFU/mL

No cross-rea ctivity

No interference

Staphylococcus aureus

3.23

109CFU/mL

No cross-rea ctivity

No interference

Staphylococcus epidermidis 1.24×109CFU/m L

No cross-rea ctivity No interference

Mycobacterium tuberculosis 1.15×108CFU/mL

No cross-rea ctivity No interference

Pneumocystis jirovecii (PJP) 3.17×108CFU/m L No cross-rea ctivity No interference

An in-silico analysis was performed using the Basic Local Alignment Search Tool (BLASTp)

managed by the National Center for Biotechnology Information (NCBI) for Human

Coronavirus HKU1, Mycobacterium tuberculosis, Pneumocystis jirovecii and SARS-CoV-1

• Human Coronavirus HKU1 shows 36.74% homology across 82% of the nucleocapsid

sequence(see Annex 2 and 3), which is relatively low. However, cross-reactivity

cannot be ruled out.

• Mycobacterium tuberculosis shows no protein sequence homology with nucleocapsid

sequence. Therefore, while cross-reactivity is highly unlikely, it cannot be completely

ruled out.

• Pneumocystis jirovecii shows no protein sequence homology with nucleocapsid

sequence. Therefore, while cross-reactivity is highly unlikely, it cannot be completely

ruled out.

• SARS-CoV-1 shows 90.52% homology across 100% of the nucleocapsid sequence.

Therefore, cross-reactivity is highly likely.

Endogenous Interfering Substances

The following substances, naturally present in respiratory specimens or that may be

artificially introduced into the nasal cavity or nasopharynx, were evaluated with the iH ealth®

COVID-19 Antigen Rapid Test.

The SARS-CoV-2 target concentration in the positive samples was approximately 3 x LoD.

All samples tested in 5 replicates produced expected results, demonstrating that the

iHealth® COVID-19 Antigen Rapid Test performance was not affected by any of the 26

potentially interfering substances listed in the table below at the concentrations tested.

Substance

Concentration in

negative/positive

sample

Cross-reactivity Interference

Whole Blood 4%

No cross-rea ctivity

No interference

Mucin 0.5%

No cross-rea ctivity

No interference

Chloraseptic (Menthol) 1.5 mg/mL

No cross-rea ctivity

No interference

Chloraseptic (Benzocaine)

1.5 mg/mL

No cross-rea ctivity

No interference

Na so GEL (NeilMed)

5% v/v

No cross-rea ctivity

No interference

CVS Na sa l Drops

(Phenylephrine) 15% v/v No cross-rea ctivity No interference

Afrin (Oxymetazoline) 15% v/v

No cross-rea ctivity

No interference

CVS Nasal Spray (Cromolyn)

15% v/v

No cross-rea ctivity

No interference

Zica m

5% v/v

No cross-rea ctivity

No interference

Homeopathic (Alka lol)

1:10 dilution

No cross-rea ctivity No interference

Sore Throat Phenol Spray

15% v/v

No cross-rea ctivity No interference

Tobramycin 4 μg/m L

No cross-rea ctivity

No interference

Mupirocin

10 mg/mL

No cross-rea ctivity

No interference

Fluticasone Propionate

5% v/v

No cross-rea ctivity No interference

Tamiflu (Oseltamivir Phosphate)

5 mg/mL

No cross-rea ctivity No interference

Na socort Allergy 24 hour

（Triamcinolone） 15% v/v No cross-rea ctivity No interference

NeilMed SinuFlow Ready

Rinse

（Sodium chloride, Sodium

bicarbonate）

15% v/v No cross-rea ctivity No interference

NeilMed SinuFrin Plus

（

Oyxmetazoline HCl

）

15% v/v No cross-rea ctivity No interference

Neo-Synephrine

（

Phenylephrine ,hydrochloride)

15% v/v No cross-rea ctivity No interference

Rhinocort (Budesonide

/Glucocorticoid) 15% v/v No cross-rea ctivity No interference

Sa line na sa l spra y (Sa line ) 15% v/v

No cross-rea ctivity

No interference

Za na mivir 282.0 ng/mL

No cross-rea ctivity

No interference

Biotin 1.0 μg/mL

No cross-rea ctivity

No interference

Laundry Detergent (C12-15

pa reth-7 and sodium laureth-12

sulfa te)

1% v/v No cross-rea ctivity No interference

Dish-washing Liquid (Sodium

la uryl sulfa te) 1% v/v No cross-rea ctivity No interference

Bleach (Sodium Hypochlorite) 1%v/v

No cross-rea ctivity

No interference

Hook Effect

No high dose hook effect was observed when tested with a concentration of 1.15x 107

TCID50/mL of heat inactivated SARS-CoV-2 virus with the iHealth® COVID-19 Antigen Rapid

Te s t .

Usability Study

iHealth conducted a study to evaluate whether a home user can follow instructions provided

and can successfully perform the test steps for the iHealth® COVID-19 Antigen Rapid Test,

including nasal swab collection, adding sample to a test card, and correctly interpreting the

results.

105 lay users, including self-collection (n=52) and collection for other lay user (n=53),

participated in the study, and were instructed to self-collect or collect a sample from others

(include children), complete the required procedural steps, and interpret the test results

unassisted in a simulated home setting. After the simulated test, all the participants

completed the knowledge assessment questionnaire and usability questionnaire.

The overall success of every task completed by all subjects enrolled was determined by

unassisted professional observation. Subjects performed 96.8% (718/742) of steps/tasks

correctly, and performed 98.1% (1414/1442) of knowledge assessment questionnaires

correctly. More than 90% of all the participants stated the device is easy to use, including

sample collection, performing the test, reading and understanding the result. 94.29% of the

participants stated the instructions provided were easy to read and understood.

The sponsor also conducted additional usability study on how to prepare material when lay

user obtain Test Set 2 of the iHealth COVID-19 Antigen Rapid Test . A total of 35 lay users

participated in this study, 18 of them were guided by paper IFU and 17 of them were guided

by APP. Subjects performed 100% (105/105) of steps/tasks correctly, and performed 97.7%

(171/175) of questionnaires correctly.

Flex study

The robust use of iHealth® COVID-19 Antigen Rapid Test was demonstrated by ten (10) Flex

studies: delay in result reading, extraction liquid volume variability, swab mixing expression

variability, temperature and humidity, impact of light sources, test device held at different

orientation and disturbance during analysis.

CUSTOMER HELPLINE

If you have any questions about the iHealth® COVID-19 Antigen Rapid Test or your result,

please contact our toll-free Customer Helpline on 1-855-816-7705.

SYMBOLS IN USE

Caution

Do not Reuse

Consult Instructions for Use

In Vitro Diagnostic Medical Device

Storage Temperature Limitation

Keep in a dry place

Keep away from direct sunlight

Do not use if package is damage

Manufacturer

Manufactured for iHealth Labs, Inc.

120 San Lucar Ct , Sunnyvale, CA 94086, USA

1-855-816-7705 www.ihealthlabs.com

Made in China

Rev.12/2021

iHealth ICO-3000 Operating instructions

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